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EP3576546A1 - Composition probiotique - Google Patents

Composition probiotique

Info

Publication number
EP3576546A1
EP3576546A1 EP18707754.0A EP18707754A EP3576546A1 EP 3576546 A1 EP3576546 A1 EP 3576546A1 EP 18707754 A EP18707754 A EP 18707754A EP 3576546 A1 EP3576546 A1 EP 3576546A1
Authority
EP
European Patent Office
Prior art keywords
composition according
weight
suspension
group
fatty acids
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP18707754.0A
Other languages
German (de)
English (en)
Other versions
EP3576546B1 (fr
Inventor
Giovanni Uras
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Farmaceutici Procemsa SpA
Original Assignee
Farmaceutici Procemsa SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Farmaceutici Procemsa SpA filed Critical Farmaceutici Procemsa SpA
Priority to SI201830992T priority Critical patent/SI3576546T1/sl
Priority to SM20230346T priority patent/SMT202300346T1/it
Priority to RS20230920A priority patent/RS64676B1/sr
Priority to HRP20230981TT priority patent/HRP20230981T1/hr
Publication of EP3576546A1 publication Critical patent/EP3576546A1/fr
Application granted granted Critical
Publication of EP3576546B1 publication Critical patent/EP3576546B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings or cooking oils
    • A23D9/007—Other edible oils or fats, e.g. shortenings or cooking oils characterised by ingredients other than fatty acid triglycerides
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23D—EDIBLE OILS OR FATS, e.g. MARGARINES, SHORTENINGS OR COOKING OILS
    • A23D9/00—Other edible oils or fats, e.g. shortenings or cooking oils
    • A23D9/02—Other edible oils or fats, e.g. shortenings or cooking oils characterised by the production or working-up
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L29/00—Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/10—Foods or foodstuffs containing additives; Preparation or treatment thereof containing emulsifiers
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/135—Bacteria or derivatives thereof, e.g. probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/66—Microorganisms or materials therefrom
    • A61K35/74—Bacteria
    • A61K35/741—Probiotics
    • A61K35/744—Lactic acid bacteria, e.g. enterococci, pediococci, lactococci, streptococci or leuconostocs
    • A61K35/747—Lactobacilli, e.g. L. acidophilus or L. brevis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N1/00—Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
    • C12N1/20—Bacteria; Culture media therefor
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

Definitions

  • the present invention concerns probiotical suspensions.
  • Probiotical formulations for example lactobacilli, are normally sold in the form of suspensions to be reconstituted at the moment of use or alternatively in the form of anhydrous suspensions in an oily carrier. These formulations are necessary since probiotics require an anhydrous environment in order to survive. In fact, the presence of water affects the long-term stability, i.e. microbial count, in the formulation .
  • suspensions are thermodynamically unstable systems, subject to particle sedimentation and re-aggregation.
  • This physical form allows the administration of insoluble solids in a given solvent in more readily bioavailable pharmaceutical formulations.
  • the larger particles deposit sediment more quickly, but can be easily re- dispersed by stirring; the smaller particles sediment more slowly, but are prone to caking.
  • R radius of dispersed particles
  • ⁇ viscosity of continuous phase.
  • the dimensions of the particles are also important: the smaller they are, the lower the sedimentation velocity; however, excessively small dimension entails a significant increase in the overall specific surface of the dispersed mass and therefore an increase in instability.
  • the very fine subdivision of the particles can also facilitate undesired adsorption phenomena; for these reasons, with the exception of the suspensions to be reconstituted prior to use, the phenomenon of flocculation is exploited.
  • This technique consists in making the particles aggregate as floes, able to retain within them a part of solvent. The floes precipitate more rapidly than the particles, but since they constitute a fairly voluminous sediment, they can be easily redispersed.
  • the sedimentation velocity of the floes is such as to guarantee a homogeneous suspension at least for the time necessary for withdrawal of the dose to be administered; this can be easily obtained with appropriate thickening agents ensuring that they are present in quantities such as to permit stirring and flux of the suspension, at the operating temperatures typical for the desired application.
  • the known probiotical formulations are commonly suspensions in an oily carrier, for example maize (corn) oil, olive oil or sunflower oil or triglycerides.
  • oily carrier for example maize (corn) oil, olive oil or sunflower oil or triglycerides.
  • Said formulations are for example suitable for the treatment of infantile colic.
  • the object of the present invention is therefore to provide a probiotical suspension without the drawbacks listed above. Said object is achieved by the present invention relative to a composition according to claim 1.
  • a composition in the form of an anhydrous suspension in an oily carrier of probiotics comprising at least one vegetable fat with a saturated fatty acid content of at least 25% by weight of the weight of the vegetable fat and therefore solid at ambient temperature.
  • the presence of the vegetable fat solid at ambient temperature allows thickening of the continuous phase of the suspension, overcoming the technical limit not possible with the excipients currently permitted and limited by the current law, while maintaining the visual characteristics and simplicity of use of a normal oily suspension.
  • probiotic we mean a live non ⁇ pathogenic organism which, administered in an adequate quantity, is beneficial for the health of the host.
  • probiotics useful for the present invention include milk enzymes and bacteria, such as lactobacilli, bifidobacteria, streptococci, lactococci, propionylbacteria, and sporogenes and yeasts, such as yeasts of the genus Saccharomyces like Saccharomyces boulardii.
  • oil carrier we mean a liquid anhydrous oily means based on oils, vegetable fats and derivatives .
  • the oily carrier is selected from the group consisting of at least one triglyceride of saturated fatty acids having an alkyl chain comprising between 6 and 12 carbon atoms, more preferably between 8 and 10 carbon atoms, vegetable oils and mixtures thereof.
  • the vegetable oils are selected from the group consisting of maize oil, olive oil, sunflower oil and mixtures thereof. They have been selected for their resistance to lipoperoxidation which improves conservation of the product and in particular minimizes the formation of oxidation products which could compromise the vitality of the enzymes.
  • the oily carrier is present in a quantity between 75 and 99%, preferably between 80 and 95% by weight of the total weight of the suspension.
  • the vegetable fat can be selected from the group consisting of shea butter, cocoa butter, palm oil, palm butter, shorea butter, coconut oil, coconut butter, also partially or totally hydrogenated .
  • the particular fatty acid composition of these vegetable fats and in particular the saturated portion results in the formation of a slightly gelified solution in direct proportion to the concentration added and to the ambient temperature.
  • the vegetable fat is present in a quantity ranging from 0.5 to 10%, preferably from 2 to 5% by weight of the total weight of the suspension.
  • the suspension can further contain one or more emulsifiers selected from the group consisting of E304 (ascorbyl palmitate) , E322 (lecithin) , E471 (mono and diglycerides of fatty acids) , E472c (citric esters of fatty acids) , E473 (sucrose esters of fatty acids) .
  • E304 ascorbyl palmitate
  • E322 lecithin
  • E471 mono and diglycerides of fatty acids
  • E472c citric esters of fatty acids
  • E473 sucrose esters of fatty acids
  • the solution provided by the invention is particularly suited to the suspension of probiotics selected from the group consisting of the genus Lactobacillus, such as for example L. acidophilus, L. rhamnosus, L. reuteri; and of the genus Bifidobacterium such as B. infantis, B. breve, B. longum.
  • the genus Lactobacillus such as for example L. acidophilus, L. rhamnosus, L. reuteri
  • the genus Bifidobacterium such as B. infantis, B. breve, B. longum.
  • a suspension was prepared having the composition shown in table 1.
  • the suspension is prepared by initially heating the medium- chain triglycerides to 65°C under constant stirring in the primary melter. The E471 is then added and mixed until it has completely dissolved and a uniform, clear and transparent mixture is obtained.
  • the mixture is then slowly and gradually cooled in a water bath under constant stirring; once 50°C is reached, the shea butter is added until perfectly dissolved, the solution is transparent. Cooling is continued, preferably in a cold water bath, and once the temperature of 20 °C has been reached, the solution appears slightly opalescent; the probiotic is added, carefully homogenizing to avoid all lumps, preferably in a modified atmosphere until a homogeneous suspension is obtained .

Landscapes

  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Mycology (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • Food Science & Technology (AREA)
  • Polymers & Plastics (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Nutrition Science (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Wood Science & Technology (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • Dispersion Chemistry (AREA)
  • Virology (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Fats And Perfumes (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention concerne une composition sous la forme d'une suspension anhydre dans un excipient huileux de probiotiques comprenant au moins une matière grasse végétale ayant une teneur en acides gras saturés supérieure ou égale à 25 % en poids du poids de la matière grasse végétale.
EP18707754.0A 2017-02-02 2018-02-02 Composition probiotique Active EP3576546B1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
SI201830992T SI3576546T1 (sl) 2017-02-02 2018-02-02 Probiotična sestava
SM20230346T SMT202300346T1 (it) 2017-02-02 2018-02-02 Composizione probiotica
RS20230920A RS64676B1 (sr) 2017-02-02 2018-02-02 Probiotska kompozicija
HRP20230981TT HRP20230981T1 (hr) 2017-02-02 2018-02-02 Probiotički pripravak

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102017000011632A IT201700011632A1 (it) 2017-02-02 2017-02-02 Composizione a base di probiotici
PCT/IB2018/050677 WO2018142346A1 (fr) 2017-02-02 2018-02-02 Composition probiotique

Publications (2)

Publication Number Publication Date
EP3576546A1 true EP3576546A1 (fr) 2019-12-11
EP3576546B1 EP3576546B1 (fr) 2023-08-02

Family

ID=59031302

Family Applications (1)

Application Number Title Priority Date Filing Date
EP18707754.0A Active EP3576546B1 (fr) 2017-02-02 2018-02-02 Composition probiotique

Country Status (9)

Country Link
EP (1) EP3576546B1 (fr)
DK (1) DK3576546T3 (fr)
FI (1) FI3576546T3 (fr)
IT (1) IT201700011632A1 (fr)
LT (1) LT3576546T (fr)
PT (1) PT3576546T (fr)
RS (1) RS64676B1 (fr)
SI (1) SI3576546T1 (fr)
WO (1) WO2018142346A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022263976A1 (fr) * 2021-06-16 2022-12-22 Societe Des Produits Nestle Sa Procédé d'enrobage de croquettes sèches par des probiotiques à l'aide de graisse comme vecteur, et croquettes sèches fabriquées au moyen de tels procédés

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2025133941A1 (fr) * 2023-12-18 2025-06-26 Labomar S.P.A. Compositions pour améliorer la dispersion de probiotiques dans des suspensions huileuses

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ITMI20012450A1 (it) * 2001-11-21 2003-05-21 Vito Alloisio Preparazione di grassi alimentari in tubetti
EP2073643A2 (fr) * 2006-10-18 2009-07-01 DSMIP Assets B.V. Encapsulation de substances sensibles à la chaleur et à l'humidité
IT1400821B1 (it) * 2009-03-09 2013-07-02 Probiotical Spa Sospensione oleosa contenente batteri probiotici per uso pediatrico
WO2010122107A1 (fr) * 2009-04-23 2010-10-28 Bacterfield International S.A. Suspension d'huile probiotique et utilisation associee
US20120076895A1 (en) * 2009-04-23 2012-03-29 Bacterfield Ou Extruded food products comprising probiotic micro-organisms
DE102011009798B4 (de) * 2011-01-31 2015-03-05 Merz Pharma Gmbh & Co. Kgaa Balneologische lipidhaltige probiotische Zubereitungen für kosmetische / dermatologische / medizinische Anwendungen
BE1024031B1 (fr) * 2014-08-28 2017-10-31 Vesale Pharma Sa Formulation huileuse comprenant au moins une bacterie probiotique.
CN105707897A (zh) * 2016-02-02 2016-06-29 上海交大昂立股份有限公司 一种益生菌脂性混悬液滴剂及其制备方法
JP6181254B1 (ja) * 2016-08-11 2017-08-16 日東薬品工業株式会社 乳酸菌含有チョコレートおよびその製造方法
US11103544B2 (en) * 2016-12-30 2021-08-31 Ann And Robert H. Lurie Children's Hospital Of Chicago Application of honey and bacteria in methods of treating scalp conditions and hair conditions

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022263976A1 (fr) * 2021-06-16 2022-12-22 Societe Des Produits Nestle Sa Procédé d'enrobage de croquettes sèches par des probiotiques à l'aide de graisse comme vecteur, et croquettes sèches fabriquées au moyen de tels procédés

Also Published As

Publication number Publication date
WO2018142346A1 (fr) 2018-08-09
DK3576546T3 (da) 2023-09-04
PT3576546T (pt) 2023-08-18
LT3576546T (lt) 2023-09-11
EP3576546B1 (fr) 2023-08-02
SI3576546T1 (sl) 2023-11-30
IT201700011632A1 (it) 2018-08-02
RS64676B1 (sr) 2023-11-30
FI3576546T3 (fi) 2023-10-09

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